Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT07194694
Brief Summary:
This clinical trial aims to compare the efficacy of two types of analgesic adjuvants in two groups of adult patients undergoing surgeries on unilateral inguinal hernia repair. The key questions it is expected to answer are:
To what extent do dexmedetomidine and ketamine adjuvants, when combined with bupivacaine, offer a longer analgesic period in a Transversus Abdominis Plane (TAP) block?
To investigate the time to first request pain medications and pain scores, researchers will rely on three groups:
Group A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1 mcg/kg dexmedetomidine + normal saline.
Group B (ketamine group): patients will receive 20 ml of solution containing 1 mg/kg bupivacaine + 0.5 mg/kg ketamine + normal saline.
Group C (Control Group): Patients will receive 20 ml of solution containing 1 mg/kg bupivacaine + normal saline.
Participants will:
Undergo general anesthesia in their planned hernia repair. Get injected with a TAP block dose of single ultrasound using one of the three study solutions at the completion of the surgery prior to waking.
Measure their pain at rest and coughing with particular time intervals (0, 2, 4, 6, and 12 hours) after the operation.
Take common rescue analgesic (nalbuphine) on request depending on the degree of pain.
Detailed Description:
Preoperative Assessment:
Patients scheduled for inguinal hernioplasty will be assessed preoperatively by evaluation of their medical history, laboratory investigations, and fulfillmentthe above inclusion criteria. The patient's preparation will be done by IV cannulation with an 18G cannula, and infusion of 500 ml of Ringer's solution will be started, and about 20 minutes before anesthesia induction, midazolam (0.05 mg/kg) will be received as a sedative premedication.
Intraoperative Procedures and Assessments:
After reaching the operating room, standard monitoring will be applied, which includes electrocardiography (ECG), non-invasive blood pressure, and pulse oximetry for peripheral oxygen saturation (SPO2). After preoxygenation, induction of general anesthesia will be done by IV injection of propofol (2 mg/kg), fentanyl (2 mcg/kg), atracurium (0.5 mg/kg), and inhalational isoflurane 1.2%, followed by endotracheal intubation and controlled mechanical ventilation with tidal volume 7-8 ml/kg, respiratory rate 12/min, and FIO₂ 100%. Then anesthesia will be maintained by inhalational isoflurane, atracurium 0.1 mg/kg every 20 minutes, and intraoperative fluid (Ringer's solution), which was calculated to cover the maintenance, deficit, and 3rd space requirement.
At the end of surgery an ipsilateral US-guided TAP block will be given to all the patients by placing a linear US probe (high-frequency probe 10-12 MHz) connected to a portable US unit (SonoSite, USA) in the mid-axillary plane midway between the lower costal margin and the highest point of the iliac crest with the patient in a supine position. After skin disinfection, a 22-G needle with an injection line will be inserted in plane with the probe. Once the tip of the needle is placed in the space between the internal oblique abdominal muscle and transversus abdominis muscle, and after negative suction, 5 ml of 0.9% saline will be injected to distend the transversus abdominis plane, then 20 ml of solution will be made.
Group A (Dexmedetomidine Group): patients received 20 ml solution containing 1 mg/kg bupivacaine + 1 mcg/kg dexmedetomidine + normal saline.
Group B (Ketamine Group): patients received 20 ml solution containing 1 mg/kg bupivacaine + 0.5 mg/kg ketamine + normal saline.
Group C (Control Group): Patients received 20 ml of solution containing 1 mg/kg bupivacaine + normal saline. Then discontinuation of inhalational isoflurane and reversal of muscle blockade by a neostigmine 0.05 mg/kg and atropine (0.01-0.02 mg/kg) mixture, and after fulfillment of extubation criteria, extubation was done.
Postoperative analgesic regimen:
On demand When NRS \>3: Nalbuphine (0.1 mg/kg) will be given with a maximum amount of 20 mg per dose and 160 mg per day.
Study:
NCT07194694
Study Brief:
Protocol Section:
NCT07194694